About Me

My mother was murdered by what I call corporate and political homicide i.e. FOR PROFIT! she died from a rare phenotype of CJD i.e. the Heidenhain Variant of Creutzfeldt Jakob Disease i.e. sporadic, simply meaning from unknown route and source. I have simply been trying to validate her death DOD 12/14/97 with the truth. There is a route, and there is a source. There are many here in the USA. WE must make CJD and all human TSE, of all age groups 'reportable' Nationally and Internationally, with a written CJD questionnaire asking real questions pertaining to route and source of this agent. Friendly fire has the potential to play a huge role in the continued transmission of this agent via the medical, dental, and surgical arena. We must not flounder any longer. ...TSS

The FDA wants to raise awareness among health care professionals, including
those working in reprocessing units in health care facilities, that the complex
design of ERCP endoscopes (also called duodenoscopes) may impede effective
reprocessing. Reprocessing is a detailed, multistep process to clean and
disinfect or sterilize reusable devices. Recent medical publications and adverse
event reports associate multidrug-resistant bacterial infections in patients who
have undergone ERCP with reprocessed duodenoscopes, even when manufacturer
reprocessing instructions are followed correctly. Meticulously cleaning
duodenoscopes prior to high-level disinfection should reduce the risk of
transmitting infection, but may not entirely eliminate it.

Summary of Problem and Scope:

More than 500,000 ERCP procedures using duodenoscopes are performed in the
United States annually. The procedure is the least invasive way of draining
fluids from pancreatic and biliary ducts blocked by cancerous tumors,
gallstones, or other conditions. Duodenoscopes are flexible, lighted tubes that
are threaded through the mouth, throat, stomach, and into the top of the small
intestine (the duodenum). They contain a hollow channel that allows the
injection of contrast dye or the insertion of other instruments to obtain tissue
samples for biopsy or treat certain abnormalities. Unlike most other endoscopes,
duodenoscopes also have a movable “elevator” mechanism at the tip. The elevator
mechanism changes the angle of the accessory exiting the accessory channel,
which allows the instrument to access the ducts to treat problems with fluid
drainage.

Although the complex design of duodenoscopes improves the efficiency and
effectiveness of ERCP, it causes challenges for cleaning and high-level
disinfection. Some parts of the scopes may be extremely difficult to access and
effective cleaning of all areas of the duodenoscope may not be possible. In
addition, a recent FDA engineering assessment and a growing body of literature
have identified design issues in duodenoscopes that complicate reprocessing of
these devices. For example, one step of the manual cleaning instructions in
device labeling is to brush the elevator area. However, the moving parts of the
elevator mechanism contain microscopic crevices that may not be reached with a
brush. Residual body fluids and organic debris may remain in these crevices
after cleaning and disinfection. If these fluids contain microbial
contamination, subsequent patients may be exposed to serious infections.

The FDA is closely monitoring the association between reprocessed
duodenoscopes and the transmission of infectious agents, including
multidrug-resistant bacterial infections caused by Carbapenem-Resistant
Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. In
total, from January 2013 through December 2014, the FDA received 75 MDRs
encompassing approximately 135 patients in the United States relating to
possible microbial transmission from reprocessed duodenoscopes. It is possible
that not all cases have been reported to the FDA. The agency is continuing to
evaluate information about documented and potential infections from multiple
sources, including Medical Device Reports (MDRs) submitted to the FDA, the
medical literature, the health care community, professional medical societies,
and the Centers for Disease Control and Prevention (CDC).

Recommendations for Facilities and Staff that Reprocess ERCP Duodenoscopes:

Follow closely all manufacturer instructions for cleaning and processing.
The FDA recommends adherence to general endoscope reprocessing guidelines and
practices established by the infection control community and endoscopy
professionals, as described in the Additional Resources section, below. In
addition, it is important to follow specific reprocessing instructions in the
manufacturer’s labeling for each device. Even though duodenoscopes are
inherently difficult to reprocess, strict adherence to the manufacturer’s
reprocessing instructions will minimize the risk of infection. Deviations from
the manufacturer's instructions for reprocessing may contribute to
contamination. The benefit of using cleaning accessories not specified in the
manufacturer’s instructions, such as channel flushing aids, brushes, and
cleaning agents, is not known. Report problems with reprocessing the device to
the manufacturer and to the FDA, as described below. Follow these additional
general best practices: Meticulously clean the elevator mechanism and the
recesses surrounding the elevator mechanism by hand, even when using an
automated endoscope reprocessor (AER). Raise and lower the elevator throughout
the manual cleaning process to allow brushing of both sides. Implement a
comprehensive quality control program for reprocessing duodenoscopes. Your
reprocessing program should include written procedures for monitoring training
and adherence to the program, and documentation of equipment tests, processes,
and quality monitors used during the reprocessing procedure. Refer to the
Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes:
2011 disclaimer icon consensus document for evidence-based recommendations for
endoscope reprocessing. Recommendations for Health Care Providers:

Inform patients of the benefits and risks associated with ERCP procedures.
Discuss with your patients what they should expect following the ERCP procedure
and what symptoms (such as fever or chills, chest pain, severe abdominal pain,
trouble swallowing or breathing, nausea and vomiting, or black or tarry stools)
should prompt additional follow-up. Consider taking a duodenoscope out of
service until it has been verified to be free of pathogens if a patient develops
an infection with a multidrug-resistant organism following ERCP, and you suspect
that there may be a link between the duodenoscope and the infection. Submit a
report to the manufacturer and to the FDA via MedWatch, as described below, if
you suspect that problems with reprocessing a duodenoscope have led to patient
infections. Recommendations for Patients:

Discuss the benefits and risks of procedures using duodenoscopes with your
physician. For most patients, the benefits of ERCP outweigh the risks of
infection. ERCP often treats life-threatening conditions that can lead to
serious health consequences if not addressed. Ask your doctor what to expect
following the procedure and when to seek medical attention. Following ERCP, many
patients may experience mild symptoms such as a sore throat or mild abdominal
discomfort. Call your doctor if, following your procedure, you have a fever or
chills, or other symptoms that may be a sign of a more serious problem (such as
chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and
vomiting, or black or tarry stools). FDA Activities:

The FDA is actively engaged with other government agencies, including CDC,
and the manufacturers of duodenoscopes used in the United States to identify the
causes and risk factors for transmission of infectious agents and develop
solutions to minimize patient exposure. Recent FDA activities include:

Collaboration with CDC and the Environmental Protection Agency (EPA) to
test the antibiotic-resistant organisms to assess their susceptibility to
high-level disinfectants. Exploration, with CDC, of additional potential
strategies to reduce the risk of infections, such as microbiological
surveillance testing of duodenoscopes. Communication with international public
health agencies to study the extent of the problem and identify possible
solutions being considered outside the United States. Reviews of reprocessing
validation data from each of the three manufacturers marketing duodenoscopes in
the United States (FUJIFILM, Olympus, and Pentax). The FDA continues to actively
monitor this situation and will provide updates as appropriate.

Health care personnel employed by facilities that are subject to the FDA's
user facility reporting requirements should follow the reporting procedures
established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better
understand the risks associated with medical devices. Health care providers
should submit voluntary reports of the transmission of an infection due to an
inadequately cleaned duodenoscope to the agency via the Medical Device Reporting
(MDR) process.

If, after following the manufacturer’s reprocessing instructions, a health
care provider suspects bacterial contamination—either because of an increase in
infections after ERCP, or because of the results of bacterial surveillance
culturing of duodenoscopes—we encourage the health care provider to file a
voluntary report through MedWatch, the FDA Safety Information and Adverse Event
Reporting program.

CRE, which stands for carbapenem-resistant Enterobacteriaceae, are a family
of germs that are difficult to treat because they have high levels of resistance
to antibiotics. Klebsiella species and Escherichia coli (E. coli) are examples
of Enterobacteriaceae, a normal part of the human gut bacteria, that can become
carbapenem-resistant. Types of CRE are sometimes known as KPC (Klebsiella
pneumoniae carbapenemase) and NDM (New Delhi Metallo-beta-lactamase). KPC and
NDM are enzymes that break down carbapenems and make them ineffective. Both of
these enzymes, as well as the enzyme VIM (Verona Integron-Mediated
Metallo-β-lactamase) have also been reported in Pseudomonas.

Healthy people usually do not get CRE infections – they usually happen to
patients in hospitals, nursing homes, and other healthcare settings. Patients
whose care requires devices like ventilators (breathing machines), urinary
(bladder) catheters, or intravenous (vein) catheters, and patients who are
taking long courses of certain antibiotics are most at risk for CRE
infections.

Some CRE bacteria have become resistant to most available antibiotics.
Infections with these germs are very difficult to treat, and can be deadly—one
report cites they can contribute to death in up to 50% of patients who become
infected.

*** just looking over the recent enforcement reports from FDA on Endoscopy
Equipment, I recall a recent report just a few months ago, a lengthy one, but I
don’t recall what the concern was? something about ;

‘’The parameters provided in the Laparoscopic Manual Instruments
Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the
unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization
methods’’

to many to list here, they all take up about 4/5 of the page. please see
link below and scroll down, you can’t miss all of them ;

Currently, CDC is providing consultation to the
Los Angeles County Health Department as it investigates, in collaboration with
the University of California, Los Angeles (UCLA) Medical Center, a cluster of
carbapenem-resistant Enterobacteriaceae (CRE) cases. In this
investigation, exposure to duodenoscopes—a device inserted down the throat and
used in a lifesaving procedure called endoscopic retrograde
cholangiopancreatography (ERCP)—was associated with transmission of
CRE.

The duodenoscope is different than the endoscope
used for routine upper gastrointestinal endoscopy or colonoscopy. The
duodenoscope is more intricate than other endoscopes and can be difficult to
clean and disinfect.

Infections caused by CRE are generally found in
hospitalized patients or residents in long-term-care facilities. ERCP is an
important and potentially lifesaving medical procedure that allows doctors to
evaluate and remove blockages from the channels (bile and pancreatic ducts) that
drain a patient’s liver. Use of this device can potentially avoid the need for
more invasive procedures such as surgery.

Investigators of previous outbreaks of CRE
related to duodenoscopes have identified recognized breaches of approved
cleaning protocols. In other outbreaks,
including this cluster, investigators reported finding no breach in duodenoscope
reprocessing and no evidence of defects in the duodenoscope.

This investigation highlights the challenging
and complicated nature of duodenoscope reprocessing and the potential for CRE
transmission. Today, the Food and Drug Administration (FDA) released a safety
communication about duodenoscopes: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm. The
FDA is aware of and closely monitoring the association between reprocessed
endoscopes and multidrug-resistant bacterial infections caused by CRE, such as
Klebsiella species and Escherichia coli.

CDC continues to investigate and work with FDA
and others on the optimal protocols for endoscope reprocessing. At this time,
CDC recommends facilities reprocess endoscopes as directed by the manufacturer,
typically high-level disinfection. Although sterilization is the definitive
mechanism to eradicate all microorganisms during reprocessing, several issues
potentially limit its widespread use, including longer processing and aeration
time than with disinfection, toxicity of some sterilizing agents, and potential
incompatibility with some duodenoscope devices. Until more is known, it is
important for facilities to be aware of the potential risk of CRE transmission
and that they adhere strictly to the recommended reprocessing practices,
particularly manual cleaning and drying.

CDC is working with partners including FDA, the
device manufacturers, specialty societies, subject matter experts, and state and
local health departments to further understand and address the possibility of
CRE transmission related to duodenoscopes in the following ways:

investigate potential CRE
transmission

determine which duodenoscope models are
potentially impacted;

evaluate duodenoscope cleaning, drying, and
disinfection;

assess the feasibility of using microbiologic
sampling cultures to evaluate a facility’s duodenoscope cleaning methods and
identify if bacterial contamination remains after cleaning; and

The risk to patients of CRE infection following
ERCP is low and, for most patients, the benefits of this potentially lifesaving
procedure outweigh the risks.

Combating antibiotic-resistant infections is a
top priority of the Administration. The President’s FY 2016 Budget nearly
doubles the amount of federal funding for combating and preventing antibiotic
resistance to more than $1.2 billion. In September 2014, President Obama signed
Executive Order 13676 launching Federal efforts to combat the rise in
antibiotic-resistant bacteria. The Administration has also issued its National
Strategy on Combating Antibiotic-Resistant Bacteria, which outlines steps the
U.S. government will take to improve prevention, detection, and control of
resistant pathogens.

This outbreak also highlights the importance of
CDC and state health departments working collaboratively to identify and stop
outbreaks of antibiotic resistant pathogens. In the FY 16 budget, CDC has
requested funding to support State Antibiotic Resistance Prevention Programs in
all 50 states and 10 large cities and a regional lab network to help identify
and to respond faster to these outbreaks. This funding would provide critical
national infrastructure to prevent the growing threat of CRE and other
drug-resistant pathogens.

ABSTRACT

ImportanceCarbapenem-resistant Enterobacteriaceae (CRE) producing the New Delhi
metallo-β-lactamase (NDM) are rare in the United States, but have the potential
to add to the increasing CRE burden. Previous NDM-producing CRE clusters have
been attributed to person-to-person transmission in health care
facilities.

Design, Setting, and
ParticipantsOutbreak investigation among 39 case patients at a
tertiary care hospital in northeastern Illinois, including a case-control study,
infection control assessment, and collection of environmental and device
cultures; patient and environmental isolate relatedness was evaluated with
pulsed-field gel electrophoresis (PFGE). Following identification of a likely
source, targeted patient notification and CRE screening cultures were
performed.

Main Outcomes and MeasuresAssociation between exposure and acquisition of NDM-producing CRE; results
of environmental cultures and organism typing.

ResultsIn total, 39
case patients were identified from January 2013 through December 2013, 35 with
duodenoscope exposure in 1 hospital. No lapses in duodenoscope reprocessing were
identified; however, NDM-producing Escherichia coli was recovered from a
reprocessed duodenoscope and shared more than 92% similarity to all case patient
isolates by PFGE. Based on the case-control study, case patients had
significantly higher odds of being exposed to a duodenoscope (odds ratio [OR],
78 [95% CI, 6.0-1008], P < .001). After the hospital changed its
reprocessing procedure from automated high-level disinfection with
ortho-phthalaldehyde to gas sterilization with ethylene oxide, no additional
case patients were identified.

Conclusions and RelevanceIn this investigation, exposure to duodenoscopes with bacterial
contamination was associated with apparent transmission of NDM-producing E
coli among patients at 1 hospital. Bacterial contamination of duodenoscopes
appeared to persist despite the absence of recognized reprocessing lapses.
Facilities should be aware of the potential for transmission of bacteria
including antimicrobial-resistant organisms via this route and should conduct
regular reviews of their duodenoscope reprocessing procedures to ensure optimal
manual cleaning and disinfection.http://jama.jamanetwork.com/article.aspx?articleid=1911326

not that it matters much, but I tried warning the fda and manufactures of
endoscopy equipment over 14 years ago of risk factors from the TSE Prion aka mad
cow type disease and endoscopy equipment. again, nobody listened.

you might want to look at the December 2014 FDA recall list I listed in
this blog. I do not advertise or make money from this research I do on the
science. it is for educational use. just made a promise to mom, never forget,
and never let them forget...

Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes
contaminated during neurosurgery.

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

Laboratory of Central Nervous System Studies, National Institute of

Neurological Disorders and Stroke, National Institutes of Health,

Bethesda, MD 20892.

Stereotactic multicontact electrodes used to probe the cerebral cortex of a
middle aged woman with progressive dementia were previously implicated in the
accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger
patients. The diagnoses of CJD have been confirmed for all three cases. More
than two years after their last use in humans, after three cleanings and
repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were
implanted in the cortex of a chimpanzee. Eighteen months later the animal became
ill with CJD. This finding serves to re-emphasise the potential danger posed by
reuse of instruments contaminated with the agents of spongiform
encephalopathies, even after scrupulous attempts to clean them.

*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies.

Hello Sir, I understand that Olympus has issued a letter to the medical
institutions and the CDC, about the dangers of _not_ being able to decontaminate
the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes
in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C).
I understand that; "Olympus" has issued a warning, _not_ to attempt to
decontaminate the instrument, that they are instructed to destroy them.

(very very wise move);

Please Sir, it is imminent that I receive a copy of this letter, it is very
important. This could lead to other company's following through, and lead to
awareness of the potential health threats from human T.S.E.'s and the risks
through surgery, and not just from endoscopes. It would be most appreciated, if
you could send a copy of this document to;

Fax: xxxxx

I look forward, to hearing back from you....

Many Thanks,

Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD

Subject: Re: CJD * Olympus Endoscope

Date: Tue, 12 Oct 1999 15:57:03 –0500

From: "Terry S. Singeltary Sr."

To: GOLDSS@...

References: 1

Dear Mr. Goldstine, Hello again, I hope the CDC has not changed your mind,
since our phone call, about sending me the information, in which we spoke of. I
am still waiting for the information, re-fax. Someone had told me, you would not
send me the information, but I told them you would, due to the importance of it
pertaining to public safety, and the fact, you are a Doctor. I hope you don't
disappoint me, and the rest of the public, and hide the facts, as the CDC and
NIH have for years. Olympus can be part of the Truth, or you can be part of the
cover-up. We are going to find out, sooner or later.

Hello Sir, I understand that Olympus has issued a letter to the medical
institutions and the CDC, about the dangers of _not_ being able to decontaminate
the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes
in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C).
I understand that; "Olympus" has issued a warning, _not_ to attempt to
decontaminate the instrument, that they are instructed to destroy them.

(very very wise move);

Please Sir, it is imminent that I receive a copy of this letter, it is very
important. This could lead to other company's following through, and lead to
awareness of the potential health threats from human T.S.E.'s and the risks
through surgery, and not just from endoscopes. It would be most appreciated, if
you could send a copy of this document to;

I was curious why my small rebuttal of the article described below was not
listed in this month's journal of GUT? I had thought it was going to be
published, but I do not have full text access. Will it be published in the
future? Regardless, I thought would pass on a more lengthy rebuttal of mine on
this topic, vCJD vs sCJDs and endoscopy equipment. I don't expect it to be
published, but thought you might find it interesting, i hope you don't mind and
hope to hear back from someone on the questions I posed...

Here is my short submission I speak of, lengthy one to follow below that:

>>I belong to
several support groups for victims and relatives>>of CJDs. Several
years ago, I did a survey regarding>>endoscopy equipment and how many
victims of CJDs have>>had any type of this procedure done. To my
surprise, many>>victims had some kind of endoscopy work done on
them.>>As this may not be a smoking gun, I think it
should>>warrant a 'red flag' of sorts, especially since data
now>>suggests a substantial TSE infectivity in the gut
wall>>of species infected with TSEs. If such
transmissions>>occur, the ramifications of spreading TSEs
from>>endoscopy equipment to the general public would
be>>horrible, and could potential amplify the
transmission>>of TSEs through other surgical procedures in
that>>persons life, due to long incubation and
sub-clinical>>infection. Science to date, has well
established>>transmission of sporadic CJDs with
medical/surgical>>procedures.

To the Editor: In their Research Letter, Dr Gibbons and colleagues1
reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD)
has been stable since 1985. These estimates, however, are based only on reported
cases, and do not include misdiagnosed or preclinical cases. It seems to me that
misdiagnosis alone would drastically change these figures. An unknown number of
persons with a diagnosis of Alzheimer disease in fact may have CJD, although
only a small number of these patients receive the postmortem examination
necessary to make this diagnosis. Furthermore, only a few states have made CJD
reportable. Human and animal transmissible spongiform encephalopathies should be
reportable nationwide and internationally.

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment
on the CDC's attempts to monitor the occurrence of emerging forms of CJD.
Asante, Collinge et al [1] have reported that BSE transmission to the
129-methionine genotype can lead to an alternate phenotype that is
indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD
and all human TSEs are not reportable nationally. CJD and all human TSEs must be
made reportable in every state and internationally. I hope that the CDC does not
continue to expect us to still believe that the 85%+ of all CJD cases which are
sporadic are all spontaneous, without route/source. We have many TSEs in the USA
in both animal and man. CWD in deer/elk is spreading rapidly and CWD does
transmit to mink, ferret, cattle, and squirrel monkey by intracerebral
inoculation. With the known incubation periods in other TSEs, oral transmission
studies of CWD may take much longer. Every victim/family of CJD/TSEs should be
asked about route and source of this agent. To prolong this will only spread the
agent and needlessly expose others. In light of the findings of Asante and
Collinge et al, there should be drastic measures to safeguard the medical and
surgical arena from sporadic CJDs and all human TSEs. I only ponder how many
sporadic CJDs in the USA are type 2 PrPSc?

RAPID ADVICE 17-2014 : Evaluation of the risk for public health of casings
in countries with a “negligible risk status for BSE” and on the risk of
modification of the list of specified risk materials (SRM) with regard to BSE

we have not spotted all the cases the first time around. with Nations like
the United States and Canada, organizations like the USDA, OIE, and WTO et al,
it was never about ‘spotting’ all the BSE TSE prion cases, it was more about how
not to find them. the triple BSE mad cow firewall, was and still is, nothing but
ink on paper. ...please see facts ;

***Moreover, L-BSE has been transmitted more easily to transgenic mice
overexpressing a human PrP [13,14] or to primates [15,16] than C-BSE.

***It has been suggested that some sporadic CJD subtypes in humans may
result from an exposure to the L-BSE agent.

*** Lending support to this hypothesis, pathological and biochemical
similarities have been observed between L-BSE and an sCJD subtype (MV genotype
at codon 129 of PRNP) [17], and between L-BSE infected non-human primate and
another sCJD subtype (MM genotype) [15].

EFSA and the European Centre for Disease Prevention and Control (ECDC)
recently delivered a scientific opinion on any possible epidemiological or
molecular association between TSEs in animals and humans (EFSA Panel on
Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical
BSE prions as the only TSE agents demonstrated to be zoonotic so far

*** but the possibility that a small proportion of human cases so far
classified as "sporadic" CJD are of zoonotic origin could not be excluded.

The TSE road map defining the evolution of European policy for protection
against prion diseases is based on a certain numbers of hypotheses some of which
may turn out to be erroneous. In particular, a form of BSE (called atypical
Bovine Spongiform Encephalopathy), recently identified by systematic testing in
aged cattle without clinical signs, may be the origin of classical BSE and thus
potentially constitute a reservoir, which may be impossible to eradicate if a
sporadic origin is confirmed.

*** Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans.

*** These atypical BSE cases constitute an unforeseen first threat that
could sharply modify the European approach to prion diseases.

So it has been shown -- so how would you -- there is a risk, though. There
is a theoretical risk of any herd or whatever having contamination. So how can
you mitigate even that very small risk? It has been shown that the existing
manufacturing processes could remove or inactive BSE agents if present. This is
because they're an extremely robust extraction under very harsh
conditions.SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION

The FDA has guidelines regarding TSEs that can be applied to heparin, and
these generally were developed by CBER and include control of animal sources,
which obviously is critical, selection of the type of tissue used, incorporation
of risk-reduction steps into the production process. And, of course, this is
typical for any animal source material or even human source material that we use
in other people, and so that's what we'd like to talk about today.